The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Endo Bite Block.
| Device ID | K833491 |
| 510k Number | K833491 |
| Device Name: | ENDO BITE BLOCK |
| Classification | Bronchoscope Accessory |
| Applicant | AMERICAN ENDOSCOPY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-07 |
| Decision Date | 1984-04-25 |